UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004460
Receipt number R000005344
Scientific Title Neoadjuvant chemotherapy and radiotherapy for operable breast cancer
Date of disclosure of the study information 2010/10/27
Last modified on 2017/05/08 10:51:52

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Basic information

Public title

Neoadjuvant chemotherapy and radiotherapy for operable breast cancer

Acronym

Neo CR

Scientific Title

Neoadjuvant chemotherapy and radiotherapy for operable breast cancer

Scientific Title:Acronym

Neo CR

Region

Japan


Condition

Condition

breast cancer

Classification by specialty

Breast surgery Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of anthracycline, paclitaxel and radiotherapy in the neoadjuvant setting for operable breast cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

pathological complete response rate

Key secondary outcomes

clinical response rate
disease free survival
rate of breast-conserving surgery
adverse events


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine Maneuver

Interventions/Control_1

neoadjuvant chemotherapy and radiotherapy

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit


Not applicable

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

1) biopsy-proven invasive breast cancer
2) TNM classification: T2-T4, N0-2, M0
3) HER2-negative tumor
4) PS (ECOG): 0 or 1
5) Normal bone marrow, liver and renal function
6) Patients who have never received any treatment for breast cancer
7) Written informed consent is obtained

Key exclusion criteria

1) past history of any invasive malignancy within the previous 5 years
2) past history of breast cancer or synchronous bilateral breast cancer
3) past history of radiotherapy for ipsilateral breast
4) Suspicious of allergy for radiotherapy
5) Suspicious of allergy for paclitaxel, 5FU, epirubicin or cyclophosphamide
7) Patients during uncontrollable diabetes or psychologic disorder
8) Patients who have grade3-4 neuropathy
9) Pregnant or breast-feeding
10) Any reason the physician believes that the patient is not appropriate to participate in the study

Target sample size

35


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Makoto Ishitobi

Organization

Osaka Medical Center for Cancer and Cardiovascular Diseases

Division name

Department of Breast and Endocrine Surgery

Zip code


Address

1-3-3 Nakamichi, Higashinari-ku, Osaka 537-8511, Japan

TEL

0669721181

Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Osaka Medical Center for Cancer and Cardiovascular Diseases

Division name

Department of Breast and Endocrine Surgery

Zip code


Address


TEL


Homepage URL


Email

isitobi-ma@mc.pref.osaka.jp


Sponsor or person

Institute

Osaka Medical Center for Cancer and Cardiovascular Diseases

Institute

Department

Personal name



Funding Source

Organization

Osaka Medical Center for Cancer and Cardiovascular Diseases

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2010 Year 10 Month 27 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2010 Year 10 Month 26 Day

Date of IRB


Anticipated trial start date

2010 Year 10 Month 26 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2010 Year 10 Month 27 Day

Last modified on

2017 Year 05 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005344


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name